New delivery technology could result in more children in developing
countries being immunized

February 09, 2011 09:00 AM Eastern Standard Time

PORTLAND, Ore.--(BUSINESS WIRE)--Bioject Medical Technologies Inc. (OTCBB:BJCT), a leading developer of
needle-free injection therapy systems, announces its support for efforts
to advance clinical research of intradermal delivery of vaccines in
developing-country immunization programs. Bioject will provide its
Intradermal (ID) Pen—a unique disposable-syringe jet injector (DSJI) for
ID delivery—to the World Health Organization (WHO) and PATH, an
international nonprofit organization, to advance the use of DSJIs for
use in developing countries, reducing risks associated with needle reuse
and needlestick injuries. WHO and PATH will each provide funding to
Bioject for the production of ID Pen devices for further evaluation.

Bioject's ID Pen spring-powered needle-free injector, currently under
development and not yet cleared by the FDA, is intended to be used for
intradermal injections for vaccinations and drug therapy. The system
consists of a hand-held, user-filled device that incorporates
single-use, auto-disable disposable syringes. The molded syringes have
orifices about the thickness of a human hair, through which the liquid
drug is forced into the skin. The ID Pen is designed to deliver .05 mL
or .10 mL for each injection. The injector is entirely mechanical and is
intended for administration by trained health workers.

For some vaccines, ID vaccine delivery can achieve the same results as
an intramuscular or subcutaneous injection—fully immunizing
beneficiaries but using up to 80 percent less vaccine. Reduced dosage is
appealing to immunization programs because it has the potential to
simultaneously increase vaccine availability and decrease costs
associated with vaccine delivery. Since accurate and reliable ID
delivery is difficult to ensure, particularly in low-resource settings,
new delivery technologies like Bioject’s ID Pen injector may make the
method more appropriate for use in the developing world. This could
result in more children being vaccinated, particularly in developing
countries. The ID Pen is intended to improve the safety and ease of ID
delivery of vaccines and could enable immunization programs to stretch
their vaccine supplies across a larger number of beneficiaries.

This collaboration is part of ongoing research by the Global Polio
Eradication Initiative (GPEI) to prepare for the post-eradication era of
polio, a disease slated for worldwide eradication in the near term. For
countries that perceive that the risks warrant continued immunization
against polio after eradication, inactivated polio vaccine (IPV) is
currently the only option with which to do this, and the GPEI is
studying a range of approaches to establish affordable strategies for
IPV use in low-income settings. WHO, PATH, and Bioject recently
collaborated on a research study on fractional doses of IPV delivered
intradermally using the Biojector® 2000 to infants in Oman. The study
results were published in 2010 in The New England Journal of Medicine
and showed successful ID administration in addition to potential cost
savings of the fractional dose when compared to the cost of full-dose
vaccination using a traditional needle and syringe. The hope is that
this new device could make IPV affordable for developing-country use and
stretch the limited supply of IPV, crucial for polio post-eradication
planning. At the same time, it could go a long way to getting rid of
needles altogether in routine immunization programs.

“We are very excited to enter into this new collaboration, which
advances the development of a new state-of-art needle-free ID Pen
injector, especially after learning of the exciting study results
reported in the New England Journal of Medicine using our
established B2000 device to investigate intradermal delivery of polio
vaccine. This new ID Pen injector will provide the needed technology for
delivery of vaccines and drugs using the intradermal approach and
perhaps allow a dose sparing effect,” said Dr. Richard Stout,
Bioject’s Executive Vice President and Chief Medical Officer. “We
appreciate the leadership, support and foresight of our collaborators to
help bring this innovative technology to patients, caregivers, and the
global medical community,” commented Dr. Stout.

PATH is working to expand access to vaccines by those who need them
most. This work will help advance the class of needle-free injection
technologies for developing-country immunization programs and contribute
to a body of work that improves vaccine delivery safety. DSJIs eliminate
the risk of needle reuse and needlestick injuries, and PATH is
conducting a cost-modeling analysis to see how costs to immunization
programs compare with traditional needle and syringe. PATH is also
comparing general acceptability of these alternative devices with
typical administration practices and testing effectiveness for delivery
of certain vaccines.

About Bioject

Bioject Medical Technologies Inc., based in Portland, Oregon, USA, is an
innovative developer and manufacturer of needle-free injection therapy
systems (NFITS). NFITS provide an empowering technology and work by
forcing medication at high speed through a tiny orifice held against the
skin. This creates a fine stream of high-pressure fluid penetrating the
skin and depositing medication in the tissue beneath. Bioject is focused
on developing mutually beneficial agreements with leading
pharmaceutical, biotechnology, and veterinary companies, as well as
research, global health and government organizations. For more
information about Bioject, visit www.bioject.com.

About the Global Polio Eradication Initiative

The Global Polio Eradication Initiative is spearheaded by national
governments, WHO, Rotary International, the US Centers for Disease
Control and Prevention and UNICEF. Since 1988 (the year the Global Polio
Eradication Initiative was launched), the incidence of polio has been
reduced by more than 99 percent. In 1988, more than 350,000 children
were paralyzed each year in more than 125 endemic countries. In 2010,
928 cases were reported, and only four countries remain endemic:
Afghanistan, India, Nigeria, and Pakistan.

About PATH

PATH is an international nonprofit organization that creates
sustainable, culturally relevant solutions, enabling communities
worldwide to break longstanding cycles of poor health. By collaborating
with diverse public- and private-sector partners, PATH helps provide
appropriate health technologies and vital strategies that change the way
people think and act. PATH’s work improves global health and well being.
For more information, please visit www.path.org.